ISLAMABAD: The Ministry of National Health Services (NHS) has issued a statutory regulatory order (SRO) allowing the import of non-registered or short medicines.

The SRO will be effective for two years and hospitals/institutions will be able to import life-saving medicines. However, a clearance certificate will be required from an assistant director level officer of the Drug Regulatory Authority of Pakistan (Drap).

According to the SRO, the government has exempted anti-cancer, cardiac drugs and any essential life-saving medicine which will be used by hospitals and institutions.

The imports will be made with the prior approval of Drap. The drug shall not be sold or distributed in the market. It shall be used for therapeutic purposes in hospitals or institutions only and not for the purpose of clinical trial, examination, test or analysis.

The clearance certificate must be obtained from the assistant director at the time of arrival of the shipment before the customer clearance.

A consumption or utilisation record must be maintained by the importer under the supervision of a qualified person.

Moreover, only a drug not available or not registered in Pakistan can be imported.

An official of the ministry of NHS, requesting not to be quoted, said the SRO would lead to the smuggling of medicines into Pakistan.

Currently, medicines of public sector hospitals on which it is mentioned that it is not for sale are sold in the market and there is no mechanism to check, he said.

“The SRO is ambiguous because it says that a medicine will be imported in case of its unavailability. Who will ensure that a drug is not available in the market? Moreover, even it is not mentioned in the SRO that only tertiary care hospitals can import such medicines. So all hospitals and institutions can go for the import,” he said.

“Moreover, it is strange that just an assistant director level officer of Drap will give permission to import a medicine,” he said.

Secretary NHS Naveed Kamran Baloch told Dawn that the SRO had been issued to meet the future and unexpected requirements.

“For example, in case of floods or earthquakes, a large number of medicines can be required so it will become possible to import such medicines immediately.

“Moreover, such decisions are taken by the policy board and an assistant director cannot take the decision on their own,” he said.

Published in Dawn, February 19th, 2018